A double-blind, randomized, comparative clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement/adjuvant to the treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in hematological parameters CBC RBC indices from baseline to Day 15 Day 30
研究概览
简要总结
Iron is unique among nutrients in being both essential and highly toxic. Anemia is a public health problem affecting about a third of the world’s population both in developing and in developed countries. It is known to occur at all stages of life; children aged.Liposomes are spherical vesicles characterized by a bilayer of lipids with an internal aqueous cavity. Liposome structural components are phospholipids. This phospholipid bilayer is suitable for fundamental cellular functions, such as motility and shape change, and provides the ability to mimic the biophysical properties of living cells. Liposomes are biphasic and therefore render them the ability to act as carriers for both lipophilic and hydrophilic drugs. Encapsulation of drugs in liposomes enhanced the therapeutic indices of various agents. The liposomal protection allows the iron to overcome the free gastric environment, preventing early degradation of the substance and/or its inactivation and to be absorbed directly. This mechanism provides liposomal iron a greater availability, reduces gastrointestinal side effects, and prevents iron instability in the gastrointestinal tract from being directly absorbed into the intestine and directly liberated into the liver. Consequently, this method of iron supplementation is associated with high gastrointestinal absorption, high bioavailability, and a low incidence of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender 18 to 70 years (inclusive) Subjects giving written informed consent /assent form Patients having presence of iron deficiency anemia below normal or low hemoglobin as per lab reports.
- •Non-use of any iron supplement for 2 weeks prior to enrolment to the study and to know the dosage timing of Calcium supplement if any.
- •Willing to come for regular follow-up visits.
- •In the opinion of the investigator, able to comply with the requirements of the protocol.
排除标准
- •Patients with serious cardiovascular, cerebro-vascular respiratory liver or renal disease or any other disorder.
- •Known history of hypersensitivity to herbal extracts or dietary supplements.
- •Known or suspected hypersensitivity to iron or any of the components of Investigational Product.
- •Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy.
- •Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.).
- •Evidence of alcohol or drug abuse, that may, in the opinion of the Investigator interferes with study compliance or prevents understanding of the objectives, investigational procedures or possible consequences of the study.
结局指标
主要结局
Change in hematological parameters CBC RBC indices from baseline to Day 15 Day 30
时间窗: Day 15 Day 30
次要结局
- Change in quality of life (QoL assessed by SF-36) from baseline to Day 15 Day 30(Day 15 Day 30)